NCT02767089

The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	Prednisone	Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized. Subjects are to be dosed each morning for 7 days. A 14 day washout period is required between each period. Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
DRUG	Placebo	Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2016-05-10
• Last updated: 2016-05-10

Locations

1 site across 1 country: United States